All Clinical Trials for Alprostadil

A recently completed multi-site double-blind placebo-controlled study found that bupropion
(Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a
diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain
whether bupropion will improve orgasmic function in pre-menopausal women with a primary
complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder.
This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis
of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug,
and sexual histories will be obtained. Patients who continue to meet screening
inclusion/exclusion criteria at their baseline visit will be randomly assigned to either
placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire
and activity will be assessed by patient diaries, investigator interview of sexual
functioning every two weeks, and by standardized questionnaire every four weeks. The primary
endpoint will be the increase in orgasm completion as measured by the Changes in Sexual
Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal,
sexual desire, and sexual pleasure as assessed by the CSFQ-F.

A recently completed multi-site double-blind placebo-controlled study found that bupropion
(Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a
diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain
whether bupropion will improve orgasmic function in pre-menopausal women with a primary
complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder.
This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis
of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug,
and sexual histories will be obtained. Patients who continue to meet screening
inclusion/exclusion criteria at their baseline visit will be randomly assigned to either
placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire
and activity will be assessed by patient diaries, investigator interview of sexual
functioning every two weeks, and by standardized questionnaire every four weeks. The primary
endpoint will be the increase in orgasm completion as measured by the Changes in Sexual
Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal,
sexual desire, and sexual pleasure as assessed by the CSFQ-F.

Summary of the proposed research:
The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has
been used to cause a decrease not only of the pulmonary but also of the systemic vascular
tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary
vasodilatation without affecting the systemic blood pressure as shown in preliminary
studies/case reports. No large trials exist for this type of use of the drug so far.
Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical
settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress
syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to
ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry
out a prospective, double blinded, randomized trial to show that the nebulized iloprost
decreases pulmonary hypertension selectively and improves oxygenation in ARDS.

Summary of the proposed research:
The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has
been used to cause a decrease not only of the pulmonary but also of the systemic vascular
tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary
vasodilatation without affecting the systemic blood pressure as shown in preliminary
studies/case reports. No large trials exist for this type of use of the drug so far.
Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical
settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress
syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to
ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry
out a prospective, double blinded, randomized trial to show that the nebulized iloprost
decreases pulmonary hypertension selectively and improves oxygenation in ARDS.

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria
will be enrolled and randomized to receive either active drug or matching placebo. After a
two-month, non-treatment period, patients will receive study drug for 6 months and will
record information about sexual encounters in a daily diary. Study drug will be applied
directly to the genital area 30-60 minutes before initiation of sexual activity. The
endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

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